Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12622000303741
Ethics application status
Approved
Date submitted
13/02/2022
Date registered
17/02/2022
Date last updated
19/01/2023
Date data sharing statement initially provided
17/02/2022
Type of registration
Prospectively registered

Titles & IDs
Public title
The Effect of An Electronically Delivered Mindfulness and Aerobic Exercise Intervention on Psychological Stress and Wellbeing: A Randomised Controlled Pilot and Feasibility Trial
Scientific title
The Effect of An Electronically Delivered Mindfulness and Exercise Intervention on Psychological Stress and Wellbeing in Healthy Volunteers: A Pragmatic Randomised Controlled Pilot and Feasibility Trial
Secondary ID [1] 306411 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Psychological stress 325246 0
Condition category
Condition code
Mental Health 322645 322645 0 0
Other mental health disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Concurrent Mindfulness and Exercise Intervention

Intervention Duration: 8 weeks
Distribution: All materials will be delivered online (e.g., via a webpage accessible with individual log-in details that will be made available to participants at the beginning of the trial). New materials will be made available on a weekly basis (e.g., each subsequent Monday).

Exercise Component:
The exercise component of this intervention will comprise low intensity to vigorous intensity activities that do not involve external equipment, do not involve jumping, and which are apartment friendly.

Frequency: Three sessions per week (e.g., Monday, Wednesday, Friday)
Individual Session Duration: Aim for at least 15 minutes and up to 30 minutes per session
Intensity: Light to moderate intensity (week 1 to 4) increasing to moderate to vigorous intensity (week 5 to 8).
Modality: Body movement exercises (e.g., squats, leg raises, push-ups, sit-ups).
Delivery: Guided through pre-recorded video instructions hosted online (e.g., a website)

Mindfulness Component:
The mindfulness component of this intervention will involve guided and unguided meditation practices up to 10 minutes in length. This may involve 3 - 4 different guided meditation practices per week (e.g., mindfulness of breath) and metronome beat recordings of up to 10 minutes to allow participants to perform unguided meditation (e.g., mindfulness of breath to a metronome beat). The frequency of use of particular guided and unguided meditation sessions will be at the participants' discretion.

Frequency: Daily sessions (e.g., Monday through Sunday)
Individual Session Duration: Aim for 10 minutes per day (but anything is better than nothing, e.g., 1 – 2 minutes is sufficient).
Intensity: N/A
Modality: Mindfulness of breath, body, sound, loving-kindness meditation.
Habit Training
Delivery: Guided through pre-recorded audio files hosted online (e.g., a website)

Additional Training Components:
In addition to the exercise and mindfulness activities, participants will listen to short weekly video instructions on: (1) goal setting and scheduling; (2) improving exercise performance; (3) mindfulness psychoeducation; and (4) cognitive-behaviour therapy techniques for reducing distress.

Frequency: One session per week with separate homework activities completed at the participants' discretion throughout the week (example: spending time scheduling exercise and meditation sessions in a personal timetable).
Duration: Approximately 15 minutes with separate homework activities completed at the participants' discretion throughout the week.
Intensity: N/A
Modality: Scheduling, daily planning, etc.
Delivery: Guided through pre-recorded video files hosted online (e.g., a website)

Adherence Requirements:
As a pragmatic trial there are no adherence requirements. To be reimbursed, participants will also have to access the study online portal (e.g., website) at least once per week for at least four of the eight weeks of the program.

Adherence Tracking:
Adherence to the program will be measured through weekly self-report to the Mindfulness Adherence Questionnaire (measuring quality and quantity of participants’ mindfulness practice over the past week; Hassed et al., 2021) and asking them on what days they completed mental/physical training. Objective usage data will also be collected (i.e., when participants access the online portal for the intervention materials).

References:
Hassed, C., Flighty, A., Chambers, R., Hosemans, D., Bailey, N., Connaughton, S., Lee, S., & Kazantzis, N. (2021). Advancing the Assessment of Mindfulness-Based Meditation Practice: Psychometric Evaluation of the Mindfulness Adherence Questionnaire. Cognitive Therapy and Research, 45(1), 190–204. https://doi.org/10.1007/s10608-020-10150-z
Intervention code [1] 322845 0
Behaviour
Intervention code [2] 322859 0
Treatment: Other
Comparator / control treatment
No-treatment Control:
Participants will be advised that they have been allocated to the no-treatment group and to continue life as usual with no special changes needed. There will be no special provisions on what participants can and cannot do during this period.
Control group
Active

Outcomes
Primary outcome [1] 330446 0
Psychological stress (Perceived Stress Scale; PSS-10).
Timepoint [1] 330446 0
Week 8 (i.e., after completion of the eight week intervention).
Primary outcome [2] 330447 0
Affective and hedonistic dimensions of wellbeing measured by the World Health Organization - Five Wellbeing Index (WHO-5)
Timepoint [2] 330447 0
Week 8 (i.e., after completion of the eight week intervention).
Secondary outcome [1] 406237 0
Psychological stress (Perceived Stress Scale; PSS-10).
Timepoint [1] 406237 0
Week 4 (i.e., the midpoint of the intervention)
Secondary outcome [2] 406238 0
Affective and hedonistic dimensions of wellbeing measured by the World Health Organization - Five Wellbeing Index (WHO-5)
Timepoint [2] 406238 0
Week 4 (i.e., the midpoint of the intervention)

Eligibility
Key inclusion criteria
1. You are proficient in English . For individuals whose first language is English, evidence of proficiency can include completion of secondary or higher education studies in English. For individuals whose first language is not English, evidence of proficiency can include a sufficient score on a language skills test (e.g., overall IELTS score of 6.5 with no band below 6.0).
2. You consent to being randomly allocated to a treatment or no-treatment group and understand that it is essential to remain part of that group for the duration of the study even if it is not your preferred outcome.
3. You consent to being contacted by researchers via email and mobile phone for the duration of the study.
4. You consent to all responses provided in this study being stripped of identifying information and deposited in a scientific public database (osf.io) for independent verification of results and for use of these data in future research for the betterment of human knowledge.
5. You consent to your name and email address being shared with the ISN Psychology Accounts department for the purpose of providing reimbursement.
6. You currently reside in Australia and plan to remain in Australia for the full duration of this study.
Minimum age
18 Years
Maximum age
44 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
1. Have typically engaged in more than 150 minutes of exercise per week over the past three months.
2. Have typically engaged in more than 10 minutes of mindfulness meditation per week over the past three months.
3. Currently have symptoms or a history of: acute injury, chronic injury, pain (e.g., any kind of musculoskeletal pain that affects bones, joints, ligaments, tendons, or muscles), a thermoregulatory disorder (e.g., heat stress disorder where sweat doesn’t evaporate fast enough to cool the body), a chronic disease of any kind (e.g., heart disease, arthritis, kidney disease, diabetes, or are being treated for cancer or have recently completed cancer treatment), high blood pressure, or become dizzy, lightheaded, or faint with exercise or exertion.
4. BMI is greater than or equal to 30 kg/m2
5. Are currently pregnant or have a suspected pregnancy

Responding with yes to any of the following screening questions as assessed by the Adult Pre-exercise Screening System:

1. Has your medical practitioner ever told you that you have a heart condition, or have you ever suffered a stroke? (if yes, excluded)
2. Do you ever experience unexplained pains or discomfort in your chest at rest or during physical activity/exercise? (if yes, excluded)
3. Do you ever feel faint, dizzy or lose balance during physical activity/exercise? (if yes, excluded)
4. Have you had an asthma attack requiring immediate medical attention at any time over the last 12 months? (if yes, excluded)
5. If you have diabetes (type 1 or 2) have you had trouble controlling your blood sugar (glucose) in the last 3 months? (if yes, excluded)
6. Do you have any other conditions that may require special consideration for you to exercise? (if yes, excluded)

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Allocation will involve contacting the holder of the allocation schedule who is "off-site" and who is independent of the current research.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
A randomization sequence will be created using the blockrand package (Snow, 2020) in R statistical software (v. 3.6.1; R Core Team). The procedure will use a 1:1 allocation ratio using random block sizes of 2 and 4. Randomization will be conducted by an independent third party.

References:

Snow, Greg. (2020). Blockrand: Randomization for Block Random Clinical Trials [v. 1.5]. https://CRAN.R-project.org/package=blockrand
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Primary Outcome Measures
- Psychological Stress measured using the Perceived Stress Scale (PSS-10).
- Affective wellbeing measured by the World Health Organization-5 Scale (WHO-5)

Main Research Questions
R1: Do the groups differ on the primary outcomes at week 4 (midpoint) of the trial?
R2: Do the groups differ on the primary outcomes at week 8 (endpoint) of the trial?

Hypotheses for Each Research Question
Psychological Stress (PSS-10)
H1a: Individuals allocated to the intervention will report lower psychological stress at week 4 compared to those allocated to a no-treatment control.
H2a: Individuals allocated to the intervention will report lower psychological stress at week 8 compared to those allocated to a no-treatment control.

Affective Wellbeing
H1b: Individuals allocated to the intervention will report higher affective wellbeing at week 4 compared to those allocated to a no-treatment control.
H2b: Individuals allocated to the intervention will report higher affective wellbeing at week 8 compared to those allocated to a no-treatment control.

Statistical Analysis of Primary Outcome Measures
H1a/b: A pairwise contrast of the Week 4 scores using the baseline scores (psychological stress or wellbeing, respectively), sex, age, baseline financial wellbeing, and recruitment wave as covariates (i.e., a one-factor between-groups ANCOVA model). The omnibus ANCOVA main effect is not of interest and will not be reported or interpreted. A pilot trial recommended alpha level of .25 will be used for each contrast.

H2a/b: A pairwise contrast of the Week 8 scores using the baseline scores (psychological stress or wellbeing, respectively), sex, age, baseline financial wellbeing, and recruitment wave as covariates (i.e., a one-factor between-groups ANCOVA model). A pilot trial recommended alpha level of .25 will be used for each contrast.

The primary analysis of interest will be an intention-to-treat analysis . A secondary analysis will be a per-protocol analysis where only participants who report to have completed at least three of weeks 1 to 4 will be retained for analyses at week 4, and only participants who report to have completed at least three of weeks 1 to 4 and three of weeks 5 to 8 will be retained for analyses at week 8.

Assumptions and Missing Data
Assumptions for one-factor between-groups ANCOVA will be assessed (e.g., linearity, normality, and homoskedasticity). Missing data will be handled using the procedures described in Newman, D. A. (2014). Missing Data: Five Practical Guidelines. Organizational Research Methods, 17(4), 372–411. https://doi.org/10.1177/1094428114548590.


Power Analysis
Parameter 1: Target Effect Size
It has been shown that the minimally important difference with respect to health-related quality of life questionnaires falls consistently close to a standardized mean difference (hereby d) of 0.50 standard deviations16. Therefore, this study will be designed such that a difference between posttest (and follow-up) means of a magnitude of d = 0.50 is detectable.

Parameter 2: Estimate of the pre-test covariate and post-test outcome correlation
Because the data collected in this trial will be analyzed using an ANCOVA model the sample size required for between-group comparisons at Week 4 and Week 8 can be determined from a power analysis for a simple independent groups t test and then multiplying by a variance deflation factor of 1 – rho2. See the following reference for details: 17. rho is the correlation between the pre-test covariate and the Week 4 and Week 8 outcome measure. Based on a previous study of the same measures of stress and wellbeing (Prochilo et al.; manuscript in preparation) we conservatively estimate that the correlation between pretest and Week 4 and Week 8 data for each primary outcome measure could be as small as rho = .58. Therefore, this value will be used in the power calculation. Four additional covariates have been selected for this study based on their theorized relationship with stress and wellbeing (sex, age, baseline financial wellbeing, and recruitment wave). If these covariates are associated with the outcome, they will increase power even higher, and we will require a smaller sample size. If these covariates are not associated with the outcome, they will lead to a minimal decrease in power by consuming four degrees of freedom. This is equivalent to subtracting four participants from the study. Therefore, to counteract the unlikely event where all four covariates are not associated with the outcome, we will recruit an additional four participants into the study.

Parameter 3: Alpha level
An alpha level of .25 (two-sided) will be used for each test. Schoenfeld (1980) recommends a one-sided alpha level of .25 for preliminary testing in pilot trials. We will adopt a two-sided alpha because we cannot rule out that the intervention may worsen our dependent outcome measures.

Parameter 5: Target Power
We will target 80% power in this trial. This reflects that we consider making a Type II error in this pilot and feasibility trial at 1.25 times more serious than a Type I error (i.e., alpha = .25, Type II error rate = .20; .25/.20 = 1.25). The rationale for this is that this is not a confirmatory study with policy implications, whereas our findings do not have policy implications and we do not want to erroneously miss an effect should one exist.

Parameter 6: Expected dropout rate
We expect a dropout rate up to 30%.

Power Analysis Result
The following parameters were entered into a power analysis for an independent groups t test (pwr:pwr.t.test function in R):
d = 0.50, alpha = .25 (two-sided), 1 – alpha = .80

This yielded a required sample size of 64 participants (32 per group). Inclusion of the baseline covariate decreases the required sample size to 43 participants in total. Accounting for: (1) an expected dropout rate of 30%, and (2) an event where all four additional covariates are unassociated with the outcome, we will target a sample size of 60 (30 per group).


Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
27/01/2023
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
60
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
ACT,NSW,NT,QLD,SA,TAS,WA,VIC
Recruitment outside Australia
Country [1] 24573 0
New Zealand
State/province [1] 24573 0

Funding & Sponsors
Funding source category [1] 310763 0
University
Name [1] 310763 0
ISN Psychology
Country [1] 310763 0
Australia
Primary sponsor type
University
Name
ISN Psychology
Address
ISN Psychology
R15/443 Upper Heidelberg Rd (Enter via 15 Bell Street),
Ivanhoe,
Victoria, 3079
Country
Australia
Secondary sponsor category [1] 311998 0
None
Name [1] 311998 0
Address [1] 311998 0
Country [1] 311998 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 310339 0
ISN Psychology Human Research Ethics Committee (HREC)
Ethics committee address [1] 310339 0
R15/443 Upper Heidelberg Rd (Enter via 15 Bell Street),
Ivanhoe,
Victoria, 3079
Ethics committee country [1] 310339 0
Australia
Date submitted for ethics approval [1] 310339 0
02/02/2022
Approval date [1] 310339 0
28/04/2022
Ethics approval number [1] 310339 0
220203

Summary
Brief summary
People who complete mindfulness or exercise programs tend to report improvements in mental health such as a reduction in psychological stress and an increase in wellbeing. The aim of this research project is to evaluate a newly developed mindfulness and aerobic exercise program and its effects on mental health (and on factors related to mental health) when compared to doing nothing at all. This program may go on to be used as a health and wellbeing program in the broader community.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 117294 0
Dr Guy Prochilo
Address 117294 0
ISN Psychology
R15/443 Upper Heidelberg Rd (Enter via 15 Bell Street),
Ivanhoe,
Victoria, 3079
Country 117294 0
Australia
Phone 117294 0
+61 3900 81653
Fax 117294 0
Email 117294 0
[email protected]
Contact person for public queries
Name 117295 0
Dr Guy Prochilo
Address 117295 0
ISN Psychology
R15/443 Upper Heidelberg Rd (Enter via 15 Bell Street),
Ivanhoe,
Victoria, 3079
Country 117295 0
Australia
Phone 117295 0
+61 3900 81653
Fax 117295 0
Email 117295 0
[email protected]
Contact person for scientific queries
Name 117296 0
Dr Guy Prochilo
Address 117296 0
ISN Psychology
R15/443 Upper Heidelberg Rd (Enter via 15 Bell Street),
Ivanhoe,
Victoria, 3079
Country 117296 0
Australia
Phone 117296 0
+61 3900 81653
Fax 117296 0
Email 117296 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
All of the individual participant data collected during the trial, after de-identification.
When will data be available (start and end dates)?
Immediately following publication, no end date.
Available to whom?
Anyone who wishes to access it.
Available for what types of analyses?
Any purpose.
How or where can data be obtained?
Unrestricted access via web address on the Open Science Framework (web address TBD).


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
15066Statistical analysis plan    This is described in the current trial registratio... [More Details]
15067Analytic code    This will be made available on the Open Science Fr... [More Details]



Results publications and other study-related documents

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